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A Multicenter Multinational Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Treating Colorectal Cancer Patients With Recurrent Liver Metastases Using the Litx™ System Plus Chemotherapy as Compared to Chemotherapy Only


Phase 3
18 Years
N/A
Not Enrolling
Both
Liver Metastases, Colorectal Neoplasms, Neoplasm Metastasis, Neoplasm Recurrence, Local

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Trial Information

A Multicenter Multinational Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Treating Colorectal Cancer Patients With Recurrent Liver Metastases Using the Litx™ System Plus Chemotherapy as Compared to Chemotherapy Only


Randomized, stratified, two arm study:

- Litx™ and chemotherapy arm (FOLFOX4 or FOLFIRI)

- Chemotherapy only arm (FOLFOX4 or FOLFIRI)

For patients who have progressed on FOLFIRI, they will be treated with Litx™ plus FOLFOX4
versus FOLFOX4 alone; and for patients who have progressed on FOLFOX, they will be treated
with Litx™ plus FOLFIRI versus FOLFIRI alone.

Stratification upon enrollment by chemotherapy and tumor sum of the longest diameter (SLD)
(SLD < 4 cm or SLD ≥4 cm but ≤7.5 cm).


Inclusion Criteria:



- Patients with recurrent metastatic liver lesions from colorectal cancer who
progressed on either FOLFOX or FOLFIRI

- Biopsy proven evidence of colorectal cancer

- At least one liver lesion that can be measured in one dimension at >10 mm with spiral
CT scan (CT preferred but MRI allowed)

- ECOG Performance Status 0-2

- Life expectancy of at least 16 weeks

- At least 30 days must have elapsed since the completion of any prior antineoplastic
therapy and the patient must have recovered from acute side effects before day 0

- Understanding and ability to sign written informed consent

- 18 years of age or more

- Adequate hematologic, liver and renal functions as evidenced by the following: WBC >
2.5 × 10^9/L ; Platelet Count > 100 × 10^9/L ; Hemoglobin > 90 g/L ; Neutrophils
>1.5 × 10^9/L ; PT and PTT < 1.5 Control ; SGOT, SGPT < 5 × ULN ; GGT < 5 × ULN ;
Alkaline phosphatase < 5 × ULN ; Bilirubin < 3 × ULN ; Creatinine < 1.5 × ULN

Exclusion Criteria:

- Patients who are candidates for complete surgical resection

- Patients who received bevacizimab (Avastin®) or cetuximab (Erbitux®) within 30 days
of randomization. Use of bevacizimab or cetuximab is prohibited while participating
in this study

- Patients who would require more than a total number of 12 light source applications
over three Litx™ experimental treatments (no more than 4 light sources per
treatment).

- Patients who have a single measurable tumor greater than 7.5 cm in any organ

- Target lesions irradiated within 3 months of randomization

- Patients with tumor involvement in greater than 50% of parenchyma of the liver

- Evidence of major vessel invasion of any organ

- Patients with any non-colorectal cancers except for adequately treated basal or
squamous cell skin cancer, or adequately treated stage I or II cancer from which the
patient has been disease-free for ≥ 3 years, or other cancer from which the patient
has been disease-free for ≥ 5 years

- Known sensitivity to porphyrin-type drugs or known history of porphyria

- Pregnancy or breast-feeding patients. A negative pregnancy test (urine or serum)
from women of childbearing age is required prior to enrollment. A fertile patient
must use effective contraception during participation in the study

- Concurrent participation in another clinical trial involving experimental treatment

- Any concurrent disease or condition that in the opinion of the investigator impairs
the patient's ability to complete the trial such as psychological, familial,
sociological, geographical or medical conditions which in the Principal
Investigator's opinion could compromise compliance with the objectives and procedures
of this protocol or obscure interpretation of the trial's data.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

184 weeks

Safety Issue:

No

Principal Investigator

Sy-Shi Wang, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Light Sciences Oncology

Authority:

United States: Food and Drug Administration

Study ID:

LSO-OL006

NCT ID:

NCT00440310

Start Date:

February 2007

Completion Date:

October 2011

Related Keywords:

  • Liver Metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local
  • Liver neoplasms
  • Liver metastases
  • MCRC
  • Litx™
  • LS11
  • Colorectal cancer with recurrent liver metastases
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Neoplasm Recurrence, Local
  • Recurrence
  • Liver Neoplasms

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